The present invention relates generally to medical devices and methods, and more particularly to intraluminal devices and methods for passing attachment apparatus (e.g., connector devices, staples, etc.) or connector material (e.g., suture thread, wire, cord, filament, monofilament, etc.) into or through the wall of a luminal anatomical structure (e.g., a blood vessel or other anatomical conduit) for the purpose of; i) closing the lumen of the anatomical structure, ii) forming an anastomotic junction between separate anatomical structures (or between approximated segments of the same anatomical structure), and/or iii) attaching an article (e.g., an endoluminal, extraluminal or transluminal graft) or other apparatus to the wall of the anatomical structure.
In modern medical practice, it is sometimes desirable to pass attachment apparatus (e.g., connector devices, staples, etc.) or connector material (e.g., suture thread, wire, cord, filament, monofilament, etc.) into or through the wall of a luminal anatomical structure (e.g., a blood vessel or other anatomical conduit) for the purpose of; i) closing the lumen of the anatomical structure, ii) forming an anastomotic junction between separate anatomical structures (or between approximated segments of the same anatomical structure), and/or iii) attaching an article (e.g., an endoluminal, extraluminal or transluminal graft) or other apparatus to the wall of the anatomical structure. Some of these types of medical procedures are summarized as follows:
Examples of medical procedures wherein it is desirable to close the lumen of a blood vessel include: a) procedures intended to diminish or block the flow of blood into vascular aneurysms (e.g., cerebral aneurysms); b) procedures intended to occlude the side branches which emanate from a segment of a peripheral vein (e.g., to prepare the vein segment for use as an in situ bypass conduit); c) procedures intended to occlude varicose veins; d) transvascular, catheter-based procedures for bypassing obstructed, diseased or injured arteries as described in U.S. patent application Ser. Nos. 08/730,327 and 08/730,496; e) procedures intended to block or diminish blood flow to a tumor; f) procedures intended to close congenital or acquired arteriovenous malformations; g) procedures intended to temporarily or permanently block blood flow through a vessel as an adjuvant to placement of an implant or apparatus within the blood vessel (e.g., placement of an endovascular graft for treatment of an aneurysm or other therapeutic intervention); and procedures intended to close an interstitial puncture tract or fistula which has been created for use in performing another medical procedure. Included among the catheter-based arterial bypass procedures described in co-pending application Ser. Nos. 08/730,327 and 08/730,496 is a coronary artery bypass procedure wherein a passageway-forming catheter is transluminally advanced into the coronary vasculature, and a tissue-penetrating element is passed out of the catheter and through the wall of the vessel in which the catheter is positioned to create at least one blood flow passageway (e.g., a puncture tract or interstitial tunnel) between an obstructed coronary artery and an adjacent coronary vein. Arterial blood then flows from the obstructed coronary artery into the adjacent coronary vein. In one variation of the procedure, a single arteriovenous passageway is formed (i.e., a xe2x80x9cfirstxe2x80x9d blood flow passageway) and the lumen of the coronary vein is blocked or closed off immediately proximal to such first blood flow passageway, such that arterial blood will enter the vein and will be forced to flow through the vein, in the retrograde direction. In this manner, the arterial blood from the obstructed artery may retroperfuse the myocardium through the coronary vein. In another variation of the procedure, one or more secondary arteriovenous passageways (e.g., puncture tracts or interstitial tunnels) may be formed between the coronary vein into which the arterial blood has been shunted, and the obstructed artery or another coronary artery. These secondary passageway(s) allow the rerouted arterial blood to re-enter the coronary arterial tree after having bypassed the arterial obstruction. In cases wherein such secondary blood flow passageways are formed, the lumen of the coronary vein may additionally be blocked or closed off at location(s) distal to such secondary passageway(s), to cause the rerouted arterial blood to re-enter the arterial vasculature, as desired.
Various types of anastomotic connections are frequently formed in luminal anatomical structures for the purpose of connecting opposing transected ends or openings formed in anatomical conduit(s) (e.g., blood vessel, intestine, etc.) or for connecting an opening formed in an anatomical conduit to another anatomical structure. When joining the juxtaposed ends or openings of a singular anatomical conduit which has been transected, or when joining the juxtaposed ends or openings of two (2) different anatomical conduits, such joinder(s) may be accomplished by either 1) end-to-end, 2) end-to-side , or 3) side to side anastomosis. Irrespective of which type of anastomotic connection is being formed, the usual surgical technique requires that the luminal anatomical conduit(s) be maneuvered into proximity and placed in abutting juxtaposition, such that the ends or openings of the anatomical conduit(s) are in alignment with one another. Thereafter, sutures, staples or other connecting apparatuses are passed through the walls of the juxtapositioned anatomical conduit(s) to form the desired anastomotic connection therebetween. Anastomotic connections of this type are frequently performed during surgical procedures wherein a diseased or injured segment of an anatomical conduit (e.g., blood vessel, intestine, etc.) has been resected and removed, and the opposing cut ends of the conduit are then reconnected (by end-to-end, side to side, or end to side anastomosis) to permit continued flow of bodily fluids or other matter through the conduit.
Examples of medical procedures wherein it is desirable to anchor or attach a graft or other apparatus to the wall of a blood vessel or other luminal anatomical conduit include certain endovascular grafting procedures wherein a tubular graft is placed within the lumen of an aneurysmic blood vessel to create a neo-lumen or artificial flow conduit through the aneurysm, thereby eliminating the exertion of blood pressure on the aneurysm and allowing the aneurysmic space to subsequently become filled in with granulation tissue. These endovascular grafting procedures have heretofore been used to treat aneurysms of the abdominal aorta, as well as aneurysms of the descending thoracic aorta. The endovascular grafts which have heretofore been used for these procedures typically incorporate or are combined with one or more radially expandable stents which are radially expanded in situ to anchor the tubular graft to the wall of the blood vessel at sites upstream and downstream of the aneurysm. However, in the event that these stent(s) fail to establish sound frictional engagement. with the blood vessel wall, the graft may undergo undesirable migration or slippage, or blood may leak into the aneurysmic sac (sometimes referred to as an xe2x80x9cendoleakxe2x80x9d).
Thus, in view of the above-mentioned undesirable complications associated with the use of radially expandable stents to frictionally anchor a graft or other apparatus to the wall of a blood vessel (or other luminal anatomical structure) there exists a need in the art for the development of new endoluminal suturing devices which may be used to suture the opposite ends of a endoluminal tube graft (or other article) to the surrounding wall of a blood vessel or other tubular anatomical conduit , thereby ensuring sound and permanent placement of the graft or other article. Also, in view of the other types of medical procedures described hereabove, there also exists a need in the art for the development of new transluminal methods and apparatus for closing the lumen of a luminal structure and/or for forming an anastomotic connections within or to the wall of the luminal structure.
The present invention provides intraluminal devices and methods which are useable to i) fully or partially close the lumen of a luminal anatomical structure (e.g., a blood vessel) , ii) form anastomotic junctions between or connections to luminal anatomical structure(s) and/or iii) attach an endoluminal, extraluminal or transluminal graft or other apparatus to the wall of a luminal anatomical structure.
In accordance with a first embodiment of the invention, there is provided an intraluminal device which is useable to occlude luminal anatomical structure by way of a closure device referred to herein, for purposes of convenience only, as a xe2x80x9cclock springxe2x80x9d occluder. This device comprises an elongate catheter which is insertable into a luminal structure, and a resilient coil which is advancable out of the catheter and at least partially through the wall of the luminal anatomical structure to occlude the lumen of the anatomical structure. This resilient coil may optionally have one or more engagement members (e.g., barbs or hooks) formed thereon to enhance its engagement or gripping of the anatomical structure and to prevent the coil from slipping or pulling back through the puncture tract through which it is advanced into or through the anatomical structure wall. Generally, a first end of the resilient coil is advancable out of the catheter and at least partially through the wall of the luminal structure (e.g., blood vessel) within which the catheter is positioned. Thereafter, the coil is further advanced within or outside of the wall of the anatomical structure so as to fully or partially encircle or surround the lumen of the anatomical structure (e.g., it may slidably advance around the adventitial surface of a blood vessel). The optional engagement members (hooks or barbs), if present, will protrude into, grip, adhere to or otherwise engage the wall of the luminal anatomical structure in a manner which will prevent the coil from slipping or pulling back through the puncture tract which it has formed into or through the anatomical structure wall and/or to prevent the from uncoiling in any way which would cause the lumen of the anatomical structure to return to its open configuration.
After the coil has been fully advanced out of the catheter, the catheter may be extracted and removed, leaving the coil in place. The coil is biased to a coiled or closed configuration such that it will then draw the wall of the luminal structure inwardly so as to fully or partially close the lumen of the anatomical structure.
In accordance with a second embodiment of the invention, there is provided another intraluminal device, which is useable to occlude or to form anastomoses in/attachments to a luminal anatomical structure. This second embodiment comprises a catheter and an occluder/connector apparatus which is advancable out of the catheter and at least partially through the wall of the luminal anatomical structure to occlude or for attachments to/anastomoses in that anatomical structure. For purposes of convenience only this occluder/connector apparatus will be referred to herebelow as a T-occluder/connector device. In general, this embodiment comprises an elongate catheter having a hollow puncturing member (e.g. a needle) which is advancable out of the catheter and through the wall of the anatomical structure. One or more of the T-occluder/connector device(s) is/are loaded into the lumen of the puncturing member. Each such T-occluder/connector device generally comprises an elongate link (e.g., a thread, wire, strand, cord, etc.) having first and second engagement members (e.g., crossbars, flanges, hooks, barbs, adhesive, clips, etc.) formed on either end thereof. After the catheter has been advanced to the desired site within the luminal structure, the puncturing member is advanced out of the catheter and at least partially through the wall of the luminal structure, at a first location. Thereafter a first one of the engagement members of a T-occluder/connector device is advanced out of the puncturing member to engage the wall of the luminal anatomical structure at a first location. Then, the puncturing member is retracted into the lumen of the anatomical structure and is moved or reoriented therewithin. Thereafter, the puncturing member is advanced (a second time) at least partially through the wall of the luminal anatomical structure, at a second location thereon. Thereafter, the second engagement member of that T-occluder/connector device is expelled from the puncturing member to engage the wall of the anatomical structure at the second location. This procedure may be repeated to install the desired number of T-occluder/connector devices at the desired locations about the wall of the luminal anatomical structure. When the procedure is completed, the puncturing element and catheter are removed, leaving the previously installed T-occluder/connector device(s) in place. Depending on the particular application, the link portion(s) of the T-occluder/connector device(s) may be formed of rigid, pliable, elastic, nonelastic, malleable, nonmalleable, retractable or nonretractable material to exert the desired amount of inward pulling force upon the engagement members. This inward pulling of the engagement members results in the desired occlusion of the lumen of the anatomical structure or the desired anastomosis in or attachment to its wall.
In accordance with a third embodiment of the present invention, there is provided another intraluminal device which is useable to occlude the lumen of an anatomical structure (e.g., a blood vessel) by way of a closure device referred to herebelow for purposes of convenience only as a xe2x80x9cTwist Clip Occluderxe2x80x9d. This device generally comprises an elongate catheter having an elongate twistable clip member formed of bendable (i.e., malleable) material loaded in the catheter and advance able from the catheter and at least partially through the wall of the luminal anatomical structure. After the clip member has been advanced into or around the wall of the anatomical structure, the catheter (or a secondary twisting tool) is rotated so as to twist the clip member to a closed configuration wherein it will draw the wall of the luminal anatomical structure inwardly so as to fully or partially close its lumen.
In accordance with a fourth embodiment of the present invention, there are provided catheter-based devices for installing sutures, staples or other connector apparatus into the wall of one or more luminal anatomical structure(s) (e.g., blood vessel(s), intestine(s), duct(s), or other anatomical conduit(s)). For purposes of convenience only, these devices of the present invention will be referred to herein as xe2x80x9cintraluminal suturing devicesxe2x80x9d, although it will be appreciated that various types of connector materials (e.g., wire, staples, absorbable sutures, nonabsorbable sutures, etc.) may be installed by use of these devices.
a. Inboard Needle Type
One type of intraluminal suturing device of the present invention comprises an elongate rigid or pliable catheter which is advance able into the lumen of a luminal anatomical structure, and which has i.) a tissue inlet opening into which a portion of the wall of the luminal structure may be caused to intrude (i.e., lapse, invaginate, extend inwardly, etc.) and ii.) an axially reciprocating penetrating member (e.g., a needle) having a suture thread, staple, wire or other connector material attached thereto. The penetrating member is mounted within the catheter, adjacent the tissue inlet opening and generally parallel to the longitudinal axis of the catheter, such that the penetrating member may be alternately passed back and forth through the portion(s) of the luminal structure wall which protrude into the tissue inlet opening. In operation, this inboard needle type device may be used by advancing the catheter into the lumen of the anatomical structure and causing a portion of the wall of the anatomical structure to intrude into the tissue inlet opening of the catheter such that some of the tissue is positioned in the path of the axially reciprocating penetrating member. The penetrating member, with its attached suture thread, staple or other connector material, is then passed through the intruding mass of tissue a first time. If it is desired to pass the suture material or other connector material through the wall of the anatomical structure more than once (e.g., to form an uninterrupted suture line) the catheter may then repositioned within the luminal anatomical structure (e.g., rotated and/or longitudinally advanced and/or longitudinally retracted ) and another portion of the wall of the anatomical structure will caused to intrude into the tissue inlet opening such that some of that tissue is located in the path of the axially reciprocating penetrating member. The penetrating member, with its attached suture thread, staple or other connector material, is then once again passed through the intruding mass of tissue. These operational steps are repeated as many times as necessary to form the desired anastomosis or connection.
In some applications, the suture material or other connector material will be drawn taught and knotted in the nature of a xe2x80x9cpurse stringxe2x80x9d so as to draw the wall of the anatomical structure inwardly and to fully or partially close its lumen. These operational steps may be repeated numerous times, as necessary, to form the desired anastomosis in, or connection to, the wall(s) of the luminal anatomical structure(s). In other applications, the suture material or other connector material will be knotted or tied (one or more times) without having been drawn taught, so as to allow the lumen to remain open, while forming the desired anastomotic connection in, or attachment to, the wall of the luminal structure.
b. Outboard Needle Type
An alternative type of intraluminal suturing device of the present invention generally comprises an elongate rigid or pliable catheter which is advance able into the lumen of a luminal anatomical structure, such catheter having i.) a first penetrating member lumen from which a penetrating member may pass out of a first opening in the side of the catheter, ii.) a second penetrating member lumen into which the penetrating member may pass through a second opening formed in the side of the catheter, and iii.) a preshaped, pliable penetrating member which is passable a) from the first lumen, b) out of the first opening, c)through an adjacent portion of the wall of the luminal anatomical structure, d) into the second opening and d) into the second lumen. A suture thread, or other connector material as described hereabove, is attached to the penetrating member such that it is drawn by the penetrating member through the tissue.
In operation, this outboard needle type of intraluminal suturing device may be used by advancing the catheter into the lumen of an anatomical structure such that the first and second openings of the catheter are located adjacent a first portion of the wall of the anatomical structure. The penetrating member (and the suture thread or other connector material attached thereto) is then passed from first lumen, out of the first opening, through the first portion of tissue, into the second opening and into the second lumen. In applications where it is desired to pass the suture thread or other connector material repeatedly through the wall of the anatomical structure (e.g., an uninterrupted suture line) the catheter will then be repositioned (e.g., rotated and/or longitudinally advanced and/or longitudinally retracted) such that a second portion of tissue is adjacent the first and second openings of the catheter, and the foregoing procedural steps are then repeated.
v. Fifth Embodimentxe2x80x94Device Useable to Form Attachments or Anastomoses
Further in accordance with the invention, there is provided a device for forming attachments to, or anastomoses in, a luminal anatomical structure. This device generally comprises an elongate catheter wich is insertable into the lumen of the luminal anatomical structure and a hollow needle disposed within said catheter, said needle having a sharpened distal tip, a needle lumen which extends longitudinally therethrough, and an outlet opening formed in communication with said needle lumen. The needle is advancable out of the catheter, after the catheter has been inserted into the luminal anatomical structure, such that the sharpened distal tip of the needle will puncture through the wall of the anatomical structure and the outlet opening of the needle will become situated outside of the luminal anatomical structure. At least one attachment apparatus is initially loaded into the lumen of the needle. Each attachment apparatus generally comprises a flexible link (e.g., a cord, thread, strand, or elongate member) having first and second engagement members (e.g., t-bars, flanges, arms, etc.) formed on opposite ends thereof. These engagement members are able to advance, one at a time, out of the outlet opening of the needle. While loaded in the lumen of the needle, the engagement members may be connected to one another, in a chain-like fashion, so that they may be advanced and/or retracted as a unit. After the catheter has been inserted into the luminal anatomical structure, the needle is advanced (a first time) out of the catheter and through a first location on the wall of the luminal anatomical structure. Thereafter, one engagement member is passed out of the outlet opening of the needle so that it becomes deployed outside of or within the wall of the luminal anatomical structure so as to engage the wall. The needle is then retracted into the catheter and the catheter is repositioned (e.g., rotated and/or longitudinally advanced/retracted) within the lumen of the anatomical structure. The needle is then advanced (a second time) out of the catheter and through a second location on the wall of the luminal anatomical structure. The second engagement member is then advanced out of the outlet opening of the needle so that it becomes deployed outside or within the wall of the anatomical structure and will engage the wall, adjacent the second location. The needle is then retracted into the catheter, leaving the two (2) engagement members in abutting engagement with the first and second loactions on the wall of the atomical structure, with the link portion of the attachment member traversing therebetween. Depending on the number of attachment members required to form the desired attachment or anastomosis, this procedure may then be repeated one or more times. When the desired attachment or anastomosis has been completed, the catheter and accompanying needle are removed from the body, leaving the previously installed attachment members in place. The attachment members may be formed of absorbable or non-absorbable material, depending of the nature of the application.
This embodiment of the invention may be used to attach various items (e.g., endoluminal grafts, stents) to the wall of a luminal anatomical structure, or may be utilized to form an anastomotic junction between the approximated ends of one or more anatomical conduit(s) (e.g., the opposing cut ends of a blood vessel, fallopian tube, ureter, urethra, pancreatic duct, common bile duct, esophagus, intestine, or other conduit which has been cut or resected). Further objects and advantages of the present invention may become apparent to those skilled in the art upon reading and understanding of the following detailed description, and the accompanying drawings.